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Scaling Out S.A.F.E. Firearm Across Two Health Systems as a Universal Suicide Prevention Strategy (SCALE ASPIRE)

NCT07009314 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5442

Last updated 2025-06-06

No results posted yet for this study

Summary

In this randomized controlled trial, researchers will assess the expansion of the S.A.F.E. Firearm program into adult primary care and women's health at two health systems in Michigan and Colorado that have previously implemented S.A.F.E. Firearm in pediatrics. S.A.F.E. Firearm involves a brief conversation between health care staff and patients about secure firearm storage and an offer of a free firearm cable lock. Researchers will test S.A.F.E. Firearm and a package of strategies intended to help health care staff incorporate the program into their practice. The strategies include: training, a prompt in the electronic health record, and facilitation, or tailored problem-solving support.

The study seeks to answer the following questions:

* How effective is S.A.F.E. Firearm at changing patients' firearm storage behavior?
* How effective is the implementation strategy package at increasing delivery of the S.A.F.E. Firearm program?

Some patients and health care staff will be invited to participate in surveys and/or interviews about their experiences with S.A.F.E. Firearm and the implementation strategy package.

Conditions

  • Suicide

Interventions

BEHAVIORAL

Implementation package (training, facilitation, electronic health record nudge)

Training will consist of an initial presentation on S.A.F.E. Firearm by the study team, informational resources to support program delivery, and recommendations for self-guided continuing medical education programs. Facilitation will last 6 months at each site. It may involve 1) a readiness assessment for each clinic to identify implementation barriers and develop relationships with constituents; 2) kick-off meetings at trial launch, at which staff will identify how to implement S.A.F.E. Firearm in the clinic; 3) goal-setting within the first few months of the program; 4) trouble-shooting to address barriers identified during the pre-implementation readiness assessment and emergent challenges; and 5) designing a sustainment plan to maintain the program for future years. A clinician decision support ("nudge"), designed to align with best practices within each health system, will be deployed in the EHR workflow to remind clinicians to deliver S.A.F.E. Firearm and offer a cable lock.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Henry Ford Health System

    collaborator OTHER

  • Kaiser Permanente

    collaborator OTHER

  • Michigan State University

    collaborator OTHER

  • Northwestern University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07009314 on ClinicalTrials.gov